BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23316854 · Received October 16, 2025

    Report

    Report Number
    9610816-2025-000961
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 16, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838127067
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED REMOTE CLINICAL SUPPORT (RCS) PERSONNEL WHICH INCLUDED COMMUNICATION AND REMOTE TROUBLESHOOTING WITH THE CUSTOMER. THE RCS NOTED THAT THE PACING APPLICATION WAS IN THE CARDIOVASCULAR ICU USING AN EXTERNAL PACING GENERATOR WITH EPICARDIAL PACING WHICH UTILIZES TEMPORARY LEADS PLACED DIRECTLY ON THE HEART. DURING ARRHYTHMIA MONITORING, THE MONITOR SHOWED PACED BEATS INTERMITTENTLY AND THEN SHOWED NORMAL SINUS RHYTHMS. THE RCS GAVE INSTRUCTIONS TO MOVE THE LEADS CLOSER TO THE HEART; HOWEVER, THE PROBLEM CONTINUED. THE BIOMED TRIED A DIFFERENT X3 WHICH HAD BEEN VALIDATED WITH A SIMULATOR; HOWEVER, WHEN USED WITH THE PATIENT, IT ALSO DID NOT SHOW THE PACER FLAGS. BIOMED ALSO TESTED THE ORIGINAL X3 MONITOR WITH A SIMULATOR AND CONFIRMED IT WAS WORKING CORRECTLY. BIOMED SHARD AN IMAGE OF THE ECG WAVEFORM WITH THE RCS WHO CONFIRMED THAT, BASED ON THE IMAGE PROVIDED, THE PACER SPIKES ARE EMBEDDED IN THE QRS AS "PSEUDOFUSION" BEATS. PSEUDOFUSION BEATS OCCUR WHEN INTRINSIC HEARTBEATS ARE TOO CLOSELY ALIGNED WITH THE PACED HEARTBEAT. NO ALARM WOULD BE EXPECTED IN A SITUATION SUCH AS THIS BECAUSE A BEAT OCCURRED WITHIN THE NECESSARY TIMEFRAME FOR A NORMAL HEARTBEAT. THE ALGORITHM IS NOT DESIGNED TO DETECT PSEUDOFUSION BEATS. IN ORDER TO AVOID PSEUDOFUSION BEATS, THE OPERATOR WOULD REVIEW THE DATA FROM DIFFERENT LEADS TO IDENTIFY ONE THAT HAS A BETTER READING. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS, AND THE CAUSE OF THE REPORTED PROBLEM WAS THE PACER SPIKES WERE EMBEDDED IN THE QRS, CREATING PSEUDOFUSION BEATS. THE ISSUE WAS RESOLVED BY THE RCS PROVIDING INFORMATION TO THE CUSTOMER REGARDING HOW TO AVOID "PSEUDOFUSION" BEATS. A REVIEW OF THE SERVICE HISTORY FOR THIS DEVICE SHOWS THE PROBLEM HAS NOT BEEN REPORTED AGAIN FOR THIS DEVICE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT THE MONITOR IS INTERMITTENTLY SHOWING PACER SPIKES ON THE PATIENT'S ECG RHYTHM. THE PATIENT HAS EPICARDIAL PACEMAKER LEADS WITH RATE OF 50 TO 60 BPM. MONITOR IS NOT ANALYZING THE ECG SIGNAL/RHYTHM CORRECTLY. THERE ARE NO ALARMS GENERATED. THE CUSTOMER WAS EXPECTING TO SEE PACEMAKER SPIKES ON THE SYSTEM OR FOR THE SYSTEM TO GENERATE AN ALARM INDICATING THE PACER IS NOT PACING. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253056 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 4.4 00884838127067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown